What Is Quincke's Edema?

Chemical name: Triptorelin acetate Structural formula:

Dafilin (triptorelin acetate for injection), -Prostate cancer treatment for metastatic prostate cancer. For patients who have not previously been treated with other hormones, the drug is more effective. -Precocious puberty (before girls 8 years old, boys 10 years old) -Endometriosis (stage I to IV) inside and outside the genitalia One course of treatment should be limited to 6 months (see [Adverse Reactions]). The use of triptorelin or other GnRH analogs is not recommended for the second course of treatment. -Female infertility is used in combination with gonadotropins (hMG, FSH, hCG) in the IVF-ET procedure to induce ovulation. -Treatment of uterine fibroids before surgery-In the case of anemia (hemoglobin content 8g / dl)-The duration of treatment is limited to 3 months in order to facilitate endoscopic surgery and transvaginal surgery to reduce tumor size.

Drug Name: Triptorelin acetate for injection
Hanyu Pinyin: Zhu She Yong Cu Suan Qu Pu Rui Lin

Drug type: Occupational injury medical insurance
Use classification: Gonadotropins

Duffelin ingredients

Chemical name: Triptorelin acetate Structural formula:

Molecular formula: C ₆₄ H ₈₂ N ₁₈ O ₁₃ · 2C ₂ H ₄ O ₂
Molecular weight: 1431.56
Excipients: Polylactide glycolide copolymer, mannitol, carboxymethyl cellulose, polysorbate 80

Duffelin traits

This product is almost white lyophilized or powder.

Duffelin indications

-Prostate cancer Treatment of metastatic prostate cancer.
For patients who have not previously been treated with other hormones, the drug is more effective.
-Precocious puberty (girls before 8 years old, boys before 10 years old)
-Endometriosis inside and outside the genitals (stages I to IV)
A course of treatment should be limited to 6 months (see [Adverse Reactions]). The use of triptorelin or other GnRH analogs is not recommended for the second course of treatment.
-Female infertility In vitro fertilization-embryo transfer procedure (IVF-ET), combined with gonadotropins (hMG, FSH, hCG) to induce ovulation.
-Treatment of uterine fibroids before surgery
-With anemia (hemoglobin content 8g / dl)
-In order to facilitate endoscopic surgery and transvaginal surgery, the size of the tumor is limited to 3 months.

Duffing specifications

3.75mg

Duffelin dosage

Method and route of administration:
This product can only be injected intramuscularly. Reconstitute the drug powder with the solvent provided in the kit and inject it immediately after reconstitution. The suspension obtained after reconstitution must not be mixed with other drugs.
Note : Please perform the reconstitution operation strictly according to the attached figure below. Any misoperation caused by the loss of more than the reasonable residual amount in the syringe should be recorded and reported.

dose:
Prostate cancer : 1 at a time. Inject every 4 weeks.
Precocious puberty : 50 g / kg once per body weight, injected every 4 weeks.
Endometriosis : Treatment should begin within 1-5 days of the menstrual cycle. One at a time and injected every 4 weeks.
It depends on the severity of the onset and changes in clinical indicators (including functional and organic indicators) during treatment. In principle, a course of treatment should be at least 4 months and at most 6 months. The use of triptorelin or other GnRH analogs is not recommended for the second course of treatment.
Female infertility : One intramuscular injection on the second day of the menstrual cycle. When the pituitary is desensitized (plasma estrogen <50 pg / ml), usually 15 days after the injection of this product, the combined use of gonadotropin therapy is started.
Treatment of uterine fibroids before surgery : Treatment should begin 5 days before the menstrual cycle.
Injected once every 4 weeks, each one for 3 months.

Duffelin adverse reactions

Male : In the early stage of treatment, with the transient increase in blood testosterone levels, some patients may see symptoms such as urinary tract symptoms, bone pain caused by bone metastases, and spinal cord compression caused by vertebral metastases. These symptoms will disappear after 1-2 weeks.
During treatment, the most commonly reported adverse reactions (hot flashes, decreased libido, and impotence) are associated with a decrease in plasma testosterone, which is a result of the pharmacological effects of the drug and is similar to the adverse reactions observed with other GnRH analogs.
Female : In the early stage of treatment, the symptoms of endometriosis (pelvic pain, dysmenorrhea) became exacerbated due to the transient increase in plasma estradiol level, which disappeared after 1-2 weeks. Uterine bleeding may occur within one month after the first injection.
When the drug is used to treat female infertility, the combined use of gonadotrophins can cause ovarian stimulation, which may cause ovarian hypertrophy, pelvic pain and / or abdominal pain. During treatment, the most commonly reported adverse reactions such as hot flashes, vaginal dryness, decreased sexual desire, and difficulty in sexual intercourse are related to pituitary-ovarian block. Rare reports of headaches, arthralgias, and muscle pain.
Male and female : Allergic reactions are reported, such as hives, rash, itching. Rarely, Quincke's edema occurs. Some patients experience nausea, vomiting, weight gain, high blood pressure, mood disorders, fever, abnormal vision, and pain at the injection site.
Long-term use of GnRH analogs can cause bone loss, which may cause osteoporosis.
Children : Initial ovarian stimulation may cause small amounts of vaginal bleeding in girls. Like adults, children have also reported allergic reactions such as urticaria, rash, itching, and rarely Quincke's edema. Some children develop abdominal pain, nausea, vomiting, headache, hot flashes, weight gain, hypertension, mood disorders, fever, abnormal vision, and pain at the injection site.
The above adverse reactions may occur even when the treatment has received satisfactory results. If the patient has the above adverse reactions or adverse reactions not listed in this manual, please notify the doctor immediately.

Duffelin Taboo

Those who are allergic to GnRH, GnRH analogs or any component of the drug are contraindicated.

Dufflin notes

male:
Prostate cancer At the beginning of treatment, very few cases have a single transient clinical symptom (especially bone pain). Close medical supervision should be given during the first few weeks of treatment, especially for patients with urinary tract obstruction and vertebral metastases (see [Adverse Reactions]). Similarly, patients with symptoms of spinal cord compression should also be given close medical supervision.
A transient increase in acid phosphatase was observed at the beginning of treatment.
Note: It is necessary to regularly check blood testosterone levels, which should not be higher than 1ng / ml.
Female: Before the doctor prescribes the patient, make sure the patient is not pregnant.
Infertility in women Warning: The combination of triptorelin and gonadotropin can cause a significant increase in the number of eggs retrieved for those sensitive patients, especially those with polycystic ovary syndrome. When triptorelin is used in combination with gonadotropins, different patients' ovaries respond differently to the same dose of the drug. In some cases, the same patient may have different ovarian responses in different cycles. Note: Induced ovulation should be performed under strict and regular biological tests and clinical examinations, including plasma estrogen examination and ultrasound examination (see [Adverse Reactions]). When the ovaries are overreacting, it is recommended to stop gonadotropin injections to stop the stimulation cycle.
Treatment of endometriosis and uterine fibroids before surgery Caution: Use 1 stick every 4 weeks, which usually causes low gonadotropin amenorrhea. Uterine bleeding after 1 month of treatment is abnormal; the plasma estradiol level should be verified. If it is less than 50 pg / ml, organic lesions may be checked.
After stopping treatment, ovarian function recovered, ovulation occurred on average 58 days after the last injection, and first menstruation occurred on average 70 days later. Care should be taken to take contraception one and a half months after the last injection.

Medications for pregnant women and lactating women

Pregnancy : Animal studies have not shown this drug to have teratogenic effects. Because the drugs that cause human malformations have been found to have teratogenic effects when tested in two species of animals, this product has no teratogenic effects on humans.
In clinical studies to date, a limited number of pregnant women have inadvertently used GnRH analogs, but none have experienced any teratogenicity or fetal poisoning. Nevertheless, further research is needed to understand exactly the effects of the drug on pregnancy.
Lactation : As there is no information on the drug's entry into breast milk and its possible effects on breastfed infants, the drug should not be used during breastfeeding.

Duffelin medication for children

This product is only for children with precocious puberty (girls before 8 years old, boys before 10 years old).

Duffelin medication for the elderly

There are no contraindications for the elderly to use this product (see [Precautions] and [Contraindications]).

Duffelin drug interactions

Cannot be used concurrently with drugs that increase prolactin concentration, because such drugs can reduce GnRH receptor levels in the pituitary.

Duffelin overdose

No overdose has been reported. If overdose occurs, symptomatic treatment should be given.

Duffelin pharmacology and toxicology

Pharmacology : Triptorelin is a synthetic decapeptide and is an analog of natural GnRH (gonadotropin-releasing hormone).
Animal studies and human studies have shown that long-term use of triptorelin can inhibit gonadotropin secretion after initial stimulation, thereby inhibiting testicular and ovarian function. Further studies in animals suggest another mechanism of action: direct gonad suppression by reducing the sensitivity of peripheral GnRH receptors.
Prostate cancer : The injection of triptorelin increased the early blood LH and FSH levels, and then the blood testosterone level; continued medication for 2 to 3 weeks, the blood LH and FSH levels decreased, and the blood testosterone level decreased to castrated levels. At the same time, acid phosphatase increased transiently during the initial period of treatment. Treatment can improve symptoms.
Precocious puberty : In both sexes, triptorelin can inhibit the hypersecretion of pituitary gonadotropin, which is manifested by the suppression of estradiol or testosterone secretion, the decrease of LH peak, and the increase of height age / bone age ratio. Initial gonad stimulation may cause a small amount of bleeding in the vagina, which requires treatment with medroxyprogesterone acetate or cyproterone acetate.
Endometriosis : The continuous administration of triptorelin can inhibit the secretion of estradiol, thus leaving the ectopic endometrial tissue in a resting state.
Infertility : Triptorelin can inhibit the secretion of gonadotropins (FSH and LH). This treatment ensures that the peak of LH is suppressed, thereby increasing the quality of follicle production and increasing the number of follicles.
Uterine fibroids : Studies have shown that the size of some uterine fibroids has decreased significantly, most noticeably at 3 months of treatment. Most patients have amenorrhea after the first month of treatment and need to correct anemia caused by excessive menstruation or uterine bleeding.
Toxicology : Animal toxicology studies have not shown that the drug molecule has any particular toxicity. The observed effect is related to the pharmacological properties of the drug on the endocrine system.
Absorption is complete 40 to 45 days after application.

Duffelin pharmacokinetics

After intramuscular injection of a sustained-release dosage form, the drug first undergoes an initial release phase, and then enters a regular uniform release phase, which is sustained for 28 days. The bioavailability of the drug within one month after injection was 53%.

Duffelin storage

Please store below 25 ° C.

Duffelin packaging

Inside each box: 1 bottle of lyophilized powder (transparent type glass vial), 2 ml of solvent (transparent type glass ampule), 1 syringe, 2 needles.

Duffelin validity

24 months

Duffelin Implementation Standard

JX20080018

Duffeling Production Enterprise

Ipsen Pharma Biotech

Duffelin approval date

December 31, 2006

Dufflin revision date

June 6, 2008 April 7, 2009 ^[1]